INTERMACS Chair Dr. Francis D. Pagani Visits ReliantHeart, Highlights BrioVAD® Innovation Ahead of U.S. Pivotal Trial

Recently, Dr. Francis D. Pagani, an internationally renowned expert in artificial heart clinical practice, the current chairman of the U.S. INTERMACS (Interagency Registry for Mechanically Assisted Circulatory Support), the Otto Gago Professor of Cardiac Surgery at the University of Michigan, and a consultant to BrioHealth Solutions (BrioVAD)^®Dr. Francis D. Pagani, the Principal Investigator of the U.S. clinical trial, visited BrioHealth Solutions to engage in in-depth discussions on the preparation of the U.S. clinical trial, the company’s product development, and the clinical application in China. He also participated in multiple academic exchange activities, achieving fruitful outcomes.

This time, Professor Pagani learned in detail about the company development history and product R&D history of BrioHealth Solutions. The relevant person in charge of the company focused on reporting the new generation product BrioVAD, which is about to undergo clinical trials in the United States.^®The research and development process and technical characteristics of this product have left Professor Pagani deeply impressed by its originality and advanced nature, and he highly appreciates it.

Subsequently, Professor Pagani engaged in in-depth discussions with Dr. Chen Chen, the founder of BrioHealth Solutions, as well as the company’s clinical, medical, and R&D teams. Detailed characteristics of the product’s design, specific applications of surgical tools, and experiences from clinical applications within China were thoroughly discussed. Additionally, Professor Pagani provided valuable insights and suggestions for the future development of the product from a clinical perspective.

During his visit to China, Professor Pagani visited several hospitals in the country that are carrying out the BrioHealth Solutions artificial heart project and delivered multiple academic presentations. He also conducted extensive exchanges with clinical experts in China's artificial heart field.

As BrioHealth Solutions' BrioVAD^®The principal investigator of the INNOVATE clinical trial in the United States, Professor Pagani, previously stated, "The FDA approval of the INNOVATE study is a landmark step, indicating that clinicians and patients with advanced heart failure can have more treatment options. BrioVAD^®"The system's entry into clinical evaluation represents a significant advancement in the field of heart failure, as countless patients each year find themselves in untreatable situations and continue to suffer from this severely debilitating disease."

BrioHealth Solutions has always regarded internationalization as the company's core strategy, and the approval of the U.S. clinical trial marks a significant milestone in the company’s internationalization journey, making history as the first active implantable medical device from China to be approved for clinical trials in the United States. The successful visit of Professor Pagani played a positive role in advancing the upcoming U.S. clinical trial. Professor Pagani stated that the INNOVATE clinical trial will be a perfect clinical trial.

Professor Francis D. Pagani is the current chairman of the U.S. INTERMACS, the Otto Gago Endowed Professor of Cardiac Surgery at the University of Michigan, and the lead investigator of the INNOVATE clinical trial. With 25 years of extensive clinical experience in the surgical treatment of advanced heart failure, including heart transplantation and mechanical circulatory support, complex reoperations for valvular heart disease, and surgery for coronary artery disease, he currently serves as the surgical director of the Circulatory Support Center at the University of Michigan, where he has led multiple related clinical trials. He has played key roles in several landmark trials, including the Rematch Trial and the MOMENTUM3 trial. Professor Pagani has published over 300 SCI articles and is recognized as one of the leading figures in the international field of mechanical circulatory support.

INTERMACS (Interagency Registry for Mechanically Assisted Circulatory Support), as a North American registry system, is specifically dedicated to collecting and analyzing clinical outcome data of patients with advanced heart failure who receive FDA-approved mechanical circulatory support devices (e.g., left ventricular assist devices) to improve the application of these devices and patient prognosis. Established in 2005 through a joint effort by multiple institutions, including the National Heart, Lung, and Blood Institute (NHLBI) and the U.S. Food and Drug Administration (FDA), it became part of the Society of Thoracic Surgeons (STS) National Database in 2018.

BrioHealth Solutions' Self-Developed Next-Generation Fully Magnetically Levitated Left Ventricular Assist System BrioVAD^®Received FDA IDE approval in the United States and will officially commence the INNOVATE study this year. This study is a prospective, non-blinded, multi-center non-inferiority trial that will utilize a randomized controlled design to evaluate BrioVAD.^®To evaluate the efficacy and safety in treating refractory heart failure and compare it with previously FDA-approved products.